IEC 60601-2-16-2008 医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和主要性能的特殊要求
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【英文标准名称】:Medicalelectricalequipment-Part2-16:Particularrequirementsforbasicsafetyandessentialperformanceofhaemodialysis,haemodiafiltrationandhaemofiltrationequipment
【原文标准名称】:医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和主要性能的特殊要求
【标准号】:IEC60601-2-16-2008
【标准状态】:作废
【国别】:国际
【发布日期】:2008-04
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;人工肾;定义;渗析;电器具;电气事故;电气工程;医用电气设备;电气安全;电医学;设备安全;血液透析滤过;血液透析器;血透析;血透析设备;血液滤过设备;加热;检验;使用说明书;作标记;医疗设备;医学科学;职业安全;防电击;辐射防护;安全;安全工程;安全要求;规范(验收);测试;工作场所安全
【英文主题词】:Accidentprevention;Artificialkidneys;Definitions;Dialysis;Electricappliances;Electricalaccidents;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromedicine;Equipmentsafety;Haemodiafiltration;Haemodialysers;Haemodialysis;Haemodialysisequipment;Haemofiltration;Heating;Inspection;Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Occupationalsafety;Protectionagainstelectricshocks;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Testing;Workplacesafety
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofHAEMODIALYSIS,HAEMODIAFILTRATIONandHAEMOFILTRATIONEQUIPMENT,hereafterreferredtoasHAEMODIALYSISEQUIPMENT.ThisInternationalstandarddoesnottakeintoconsiderationtheDIALYSINGFLUIDcontrolsystemofHAEMODIALYSISEQUIPMENTusingregenerationofDIALYSINGFLUIDandCENTRALDELIVERYSYSTEMS.ItdoeshowevertakeintoconsiderationthespecificsafetyrequirementsofsuchHAEMODIALYSISEQUIPMENTconcerningelectricalsafetyandPATIENTsafety.ThisInternationalstandardspecifiestheminimumsafetyrequirementsforHAEMODIALYSISEQUIPMENT.ThesedevicesareintendedforuseeitherbymedicalstafforforusebythePATIENTorothertrainedpersonnelunderthesupervisionofmedicalexpertise.ThisInternationalstandardincludesallMEEQUIPMENTthatisintendedtodeliveraHAEMODIALYSIS,HAEMODIAFILTRATIONandHAEMOFILTRATIONtreatmenttoaPATIENTsufferingfromkidneyfailure.TheparticularrequirementsinthisInternationalstandarddonotapplyto:–EXTRACORPOREALCIRCUITS;–DIALYSERS;–DIALYSINGFLUIDCONCENTRATES;–watertreatmentequipment;–equipmentusedtoperformPERITONEALDIALYSIS(seeIEC60601-2-39).IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofIEC60601-1.NOTESeealso4.2ofIEC60601-1:2005.
【中国标准分类号】:C44
【国际标准分类号】:11_040_20
【页数】:57P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和主要性能的特殊要求
【标准号】:IEC60601-2-16-2008
【标准状态】:作废
【国别】:国际
【发布日期】:2008-04
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:事故预防;人工肾;定义;渗析;电器具;电气事故;电气工程;医用电气设备;电气安全;电医学;设备安全;血液透析滤过;血液透析器;血透析;血透析设备;血液滤过设备;加热;检验;使用说明书;作标记;医疗设备;医学科学;职业安全;防电击;辐射防护;安全;安全工程;安全要求;规范(验收);测试;工作场所安全
【英文主题词】:Accidentprevention;Artificialkidneys;Definitions;Dialysis;Electricappliances;Electricalaccidents;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromedicine;Equipmentsafety;Haemodiafiltration;Haemodialysers;Haemodialysis;Haemodialysisequipment;Haemofiltration;Heating;Inspection;Instructionsforuse;Marking;Medicalequipment;Medicalsciences;Occupationalsafety;Protectionagainstelectricshocks;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Testing;Workplacesafety
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofHAEMODIALYSIS,HAEMODIAFILTRATIONandHAEMOFILTRATIONEQUIPMENT,hereafterreferredtoasHAEMODIALYSISEQUIPMENT.ThisInternationalstandarddoesnottakeintoconsiderationtheDIALYSINGFLUIDcontrolsystemofHAEMODIALYSISEQUIPMENTusingregenerationofDIALYSINGFLUIDandCENTRALDELIVERYSYSTEMS.ItdoeshowevertakeintoconsiderationthespecificsafetyrequirementsofsuchHAEMODIALYSISEQUIPMENTconcerningelectricalsafetyandPATIENTsafety.ThisInternationalstandardspecifiestheminimumsafetyrequirementsforHAEMODIALYSISEQUIPMENT.ThesedevicesareintendedforuseeitherbymedicalstafforforusebythePATIENTorothertrainedpersonnelunderthesupervisionofmedicalexpertise.ThisInternationalstandardincludesallMEEQUIPMENTthatisintendedtodeliveraHAEMODIALYSIS,HAEMODIAFILTRATIONandHAEMOFILTRATIONtreatmenttoaPATIENTsufferingfromkidneyfailure.TheparticularrequirementsinthisInternationalstandarddonotapplyto:–EXTRACORPOREALCIRCUITS;–DIALYSERS;–DIALYSINGFLUIDCONCENTRATES;–watertreatmentequipment;–equipmentusedtoperformPERITONEALDIALYSIS(seeIEC60601-2-39).IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofIEC60601-1.NOTESeealso4.2ofIEC60601-1:2005.
【中国标准分类号】:C44
【国际标准分类号】:11_040_20
【页数】:57P.;A4
【正文语种】:英语
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